Specialist, Submission Ops

Biopharma Careers; São Paulo; Presencial; BRL 90 000 - 120 000; Tempo integral

Resumo da oferta

DePuy Synthes is seeking a Specialist, Submission Ops in São Paulo, Brazil. The role focuses on validating, coordinating, and tracking regulatory submissions while ensuring compliant lifecycle management and quality documentation across global operations.

You will work with Regulatory Affairs, Quality, and other teams to ensure on‑time delivery, accurate records, and readiness for inspections, contributing to patient safety and market access in a regulated environment.

Qualificações

• 0–2 years of regulatory operations experience or a regulated environment.
• Foundational knowledge of regulatory submission processes and documentation practices.
• Strong attention to detail and ability to manage documentation accurately.
• Ability to follow defined procedures and manage multiple tasks.
• Basic data analysis and reporting to support submission tracking.

Responsabilidades

• Support preparation, assembly, publishing, and tracking of regulatory submissions.
• Maintain accurate regulatory records and submission trackers.
• Coordinate submission activities with Regulatory Affairs, Quality, and cross‑functional partners.
• Perform quality checks on submission content for accuracy and compliance.
• Support responses to health authority requests and track commitments.
• Assist with process improvements, metrics, and reporting for efficiency.
• Support local systems access management.
• Assist with contract management and payment processes.
• Apply quality, compliance, and Credo principles in submission activities.

Conhecimentos

Regulatory knowledge

Attention to detail

Documentation management

Multitasking

Communication

Formação académica

Bachelor's degree in Life Sciences, Regulatory Affairs, Quality, Engineering, or related discipline

Regulatory coursework or certification preferred

Regulatory Affairs Certification (RAC) preferred

Ferramentas

Regulatory information management systems

Descrição da oferta de emprego

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Through Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

São Paulo, Brazil

Job Description

DePuy Synthes is recruiting for a Specialist, Submission Ops, located in SãoPaulo, SãoPaulo, Brazil.

The Specialist, Submission Ops supports regulatory submission operations within QARA International, ensuring accurate, timely, and compliant preparation and lifecycle management of regulatory submissions. This role plays a critical part in enabling market access, supporting compliance with global and local regulatory requirements, and maintaining high-quality submission records. The position offers exposure to global regulatory operations and the opportunity to contribute directly to patient safety and business continuity at DePuy Synthes.

Key Responsibilities

• Support the preparation, assembly, publishing, and tracking of regulatory submissions and related documentation in accordance with internal procedures and regulatory requirements.
• Maintain accurate regulatory records, submission trackers, and document repositories to support submission lifecycle management.
• Coordinate submission activities with Regulatory Affairs, Quality, and cross‑functional partners to ensure completeness and on‑time delivery.
• Perform quality checks on submission content and formatting to ensure accuracy, consistency, and compliance with defined standards.
• Support responses to health authority requests by compiling documentation and tracking commitments under guidance from regulatory leads.
• Assist with process improvements, metrics, and reporting to enhance submission operational efficiency.
• Support local systems access management.
• Support contract management and payment processes.
• Apply DePuy Synthes and Johnson & Johnson quality, compliance, and Credo principles in all submission‑related activities.

Qualifications

Education

• Bachelor’s degree required in Life Sciences, Regulatory Affairs, Quality, Engineering, or a related discipline.
• Regulatory or quality‑related coursework or certification preferred.

Experience and Skills

Required

• Generally requires 0–2 years of relevant experience in regulatory operations, quality, or a regulated environment, aligned to a developing professional‑level role.
• Foundational knowledge of regulatory submission processes and documentation practices.
• Strong attention to detail and ability to manage documentation accurately and consistently.
• Ability to follow defined procedures and manage multiple tasks with competing priorities.
• Basic data analysis and reporting skills to support submission tracking and metrics.

Preferred

• Experience in a regulated industry such as medical devices, pharmaceuticals, or healthcare.
• Familiarity with global regulatory requirements and submission standards.
• Experience using regulatory information management or document management systems.
• Exposure to audit or inspection readiness activities.
• Experience working in a global or matrixed organization.
• Effective written and verbal communication skills.

Other

• Languages: Portuguese required; English proficiency preferred for global collaboration.
• Travel: Limited domestic or international travel may be required (generally Certifications: Regulatory Affairs Certification (RAC) or similar preferred but not required.

Additional Information

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Company Updates

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Equal Opportunity Employer Statement

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Accommodations for Disability

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.